Prevalence of tuberculosis (TB) infection and disease among adolescents western Kenya: preparation for future TB vaccine trials

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1 Prevalence of tuberculosis (TB) infection and disease among adolescents western Kenya: preparation for future TB vaccine trials Videlis Nduba 1,2, Peter Onyango 1, Anja Van t Hoog 1,3, Anthony Hawkridge 4, Kayla Laserson 1 1 KEMR/CDC Research and Public Health Collaboration 2 KEMRI/CRDR 3 University of Amsterdam 4 Aeras Global TB Vaccine Foundation

2 Background Tuberculosis (TB) is a major global public health problem with 9.3 million new cases and 1.8 million deaths in 2007 affecting mainly Africa, South-East Asia and the Western Pacific (WHO). One third of the world s population is estimated to be infected with the tuberculosis mycobacterium. Source: WHO report 2009: Global Tuberculosis Control

3 TB Burden in Kenya Nyanza Province has greatest TB burden in Kenya TB notification (all types of TB): 440/ Prevalence of TB disease (all types) 319/ in Kenya (2007) HIV prevalence in HIV-tested TB cases registered with TB program in Nyanza is ~75% (52% nationally) TB is the most common cause of death in people living with HIV. Those living with HIV have a 10% annual risk of contracting TB Kenya ranked 13th out of 22 TB high burden countries by the WHO

4 TB Vaccination Bacille Calmette Guérin (BCG) first administered in It is the mostly widely used vaccination today (about 100 million doses in 2002). However, its effectiveness is controversial. Nevertheless, there is broad consensus that it provides protection against severe forms of childhood TB.

5 KEMRI/CDC Field Station, Western Kenya

6 Karemo Division (Study Area) Under continuous demographic surveillance (DSS) Total Population 85,000 Estimated 13,000 adolescents Aged (both in and out of school) as estimated from DSS registers Divided into 17 equal sized clusters of approximately 800 adolescents each Clusters randomized to give each adolescent in the study area an equal probability of getting enrolled into the study

7 Adolescents as a target group for research Adolescents considered a high risk group for TB disease and difficult to recruit Captive population (in schools), access easier than mobile young adult population Attrition in progressing years of education a matter of concern for retention in clinical trials The planned epidemiological study involves invasive procedures We would expect this to potentially impact negatively on recruitment Little information in literature for TB in adolescents; Important to determine prevalence and incidence of TB disease in adolescents

8 Methods Prospective Cohort Study of 5000 Adolescents Aged years Clusters randomly approached for enrollment. Potential study subjects identified through DSS registers Parental consent and adolescent assent sort All consenting adolescents in a cluster enrolled until the full sample size achieved A questionnaire about symptoms, history of contact with a TB case and history of hospitalization administered Follow up every 4 months for 1-2 years TB suspects identified through: History of Contact with a TB case Clinical History Tuberculin skin tests (TST) (considered positive when) 10mm if HIV negative 5mm if HIV positive TB suspects evaluated through: HIV testing sputum microscopy and culture Chest x-rays Analysis Cluster adjusted estimates of prevalence and infection

9 Informed consent and adolescent assent are conducted at home and schools respectively Adolescents and their parents are invited to a central site usually in a school where enrollment activities take place Not all consenting parent/adolescent pairs showed up for enrollment Enrollment conducted on Thursday and Friday while tuberculin skin tests are read on Monday and Tuesday Mobile Field Site

10 Results (1) Refusals 37 (0.9%) Moved out of study area 103(2.5%) Resident but not found 50(1.2%) 4160 Adolescents identified from the DSS register 3944 (94.8%) Consented 1791 (48.4%) Female Median age 14 yrs 3701 (89%) 6/17 clusters Enrolled 1361 (36.8%) TB suspects HIV test Offered to all TB suspects 1223/1361 (89.7%) Received HIV test 15 (1.2%) HIV Positive 10 had TST 10mm

11 Results(2) 1361 TB suspects Contact Symptoms Positive TST 144/3701 (3.9%) 422/3701 (11.4%) 1133/3701 (32.2%) Prevalence of TB infection Adjusted for cluster sampling 32.2% CI (28.2, 36.2)

12 TB cases 12 definite pulmonary TB (PTB) cases (2 fluorescent microscopy smear positive or culture positive (MTB on speciation) 4 probable PTB cases (clinically diagnosed but not culture or smear positive) 14/16 (87.5%) of TB cases had a positive tuberculin skin test. None of the TB cases was HIV positive prevalence estimates adjusted for cluster sampling: 324/100,000 (definite) CI (157, 491) per 100,000 population 432/100,000 (definite and probable) CI( ) per 100,000 population

13 Discussion The prevalence of pulmonary disease among adolescents is similar to what was found in a recent prevalence survey, western Kenya by Anja Van t Hoog et al in year olds for bacteriologically confirmed PTB (290/ % CI(99-480) The prevalence of TB infection (32.2%) is higher than reported previously in TST surveys in Kenya for school going children average age 8.4years (5.5%) whose estimated annual risk of infection was 0.6%. None of the identified prevalent TB cases presented had been diagnosed by the TB program

14 Conclusion The interim prevalence of TB is consistent with our expectations and indicates this will be a suitable target population for TB vaccine trials The ability to rapidly enroll adolescents shows this will be a suitable site to conduct clinical trials in adolescents especially TB vaccine trials

15 Acknowledgement Funding Agencies: European and Developing Countries Clinical Trials Partnership (EDCTP) Aeras Global TB Vaccine Foundation NACCAP KNCV Tuberculosis Foundation Collaborators: Ministry of Health Ministry of Education South African Tuberculosis Vaccine Initiative Vienna School of Clinical Research SRL Milan, Italy Community in Karemo, Siaya District Study team

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